The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).

To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 5% of baseline body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on the absolute change in body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including waist circumference [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in systolic blood pressure [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including fasting glucose [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including eating behavior [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 10% of baseline body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 15% of baseline body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting triglycerides [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting HDL cholesterol [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in diastolic blood pressure [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in heart rate [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including fasting insulin [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including homeostasis model assessment - insulin resistance (HOMA-IR) [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including sexual function [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including weight related quality of life [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

Other Outcome Measures:

To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 5% of baseline body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 10% of baseline body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 15% of baseline body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on the absolute change in body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including waist circumference [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting triglycerides [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting LDL cholesterol [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting HDL cholesterol [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in systolic blood pressure [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in diastolic blood pressure [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in heart rate [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including fasting glucose [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including fasting insulin [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including homeostasis model assessment - insulin resistance (HOMA-IR) [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including eating behavior [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including sexual function [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including weight-related quality of life [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01764386